Status:
COMPLETED
NRX-101 for Bipolar Depression With Subacute Suicidal Ideation
Lead Sponsor:
NeuroRx, Inc.
Collaborating Sponsors:
Prevail Infoworks
Conditions:
Bipolar Depression
Suicidal Ideation and Behavior
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the trea...
Detailed Description
Background and Rationale: NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NRX-101 is composed of D-cycloserine (DCS) an NMDA antagonist and lurasidone (5HT2a a...
Eligibility Criteria
Inclusion
- Diagnosed with bipolar disorder by a qualified rater according to the criteria defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and supported by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
- Confirmed active suicidal ideation (without the intention to act) as evidenced by an answer of 'Yes' on item 3 and/or item 4 and not requiring hospitalization at Screening and an answer of "No" on item 5 of the C-SSRS.
- A total score greater than or equal to 30 on the 10 items of the MADRS.
- Subject has no co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG)
Exclusion
- Subject has current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening.
- Subject has a lifetime history of:
- phencyclidine (PCP)/ketamine drug abuse, or
- failed use of ketamine for depression or suicidality.
- Subject has schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
- Subject has a current major psychiatric disorder, diagnosed at Screening
- Subject has been prescribed more than one agent in each of the following categories at randomization:
- Approved SSRIs
- Approved serotonin and norepinephrine reuptake inhibitors (SNRIs)
- Approved tetracyclic antidepressants (TeCAs)
- Approved Mood stabilizers (e.g., lithium, valproic acid, and lamotrigine)
- Subject has signs and symptoms of active or residual COVID-19, or unresolved symptoms of COVID-19 that impact health
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03395392
Start Date
May 12 2022
End Date
March 30 2024
Last Update
May 8 2024
Active Locations (14)
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1
Science 37
Culver City, California, United States, 90320
2
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States, 33014
3
ACMR
Atlanta, Georgia, United States, 30331
4
iResearch Atlanta, LLC
Decatur, Georgia, United States, 30030